Detailed Narrative
iDose TR Commercial Momentum and Market Access
Glaukos' iDose TR generated $74 million in Q2 sales, driving 64% YoY growth in the U.S. glaucoma franchise. The company is focused on expanding trained surgeons, increasing utilization, and broadening market access, supported by 24 peer-reviewed publications and active Phase IV studies. Recent CMS proposed rules for 2027 largely maintain existing APC assignments and physician fee rates, and the company is encouraged by strong stakeholder support for iDose TR's local coverage determinations from Medicare administrative contractors.
Epioxa Launch Progress and Market Penetration
Epioxa contributed $11 million in Q2 sales, fueling 48% YoY growth in Corneal Health. The launch priorities include expanding the site of care network, which now covers 85% of the U.S. population with a pipeline to reach 95%. Access pathways are established for over 125 million covered commercial lives, including the 5 largest payers. The new product-specific J-code, J2789, became effective on July 1, 2026, expected to streamline reporting and reimbursement.
Robust Clinical Pipeline Advancements
Glaukos is advancing a broad pipeline across five therapeutic platforms. Key milestones include a Phase IIb/III program for iDose TREX and a Phase IIIb study for iDose TRIO targeting FDA approval by end of 2027. The company plans commercial introduction of a KC screening device later this year and a Phase III program for a third-generation iLink therapy in 2027. Enrollment is complete for iStent infinite's PMA pivotal trial and PRESERFLO MicroShunt's 510(k) pivotal study, with iLution Demodex blepharitis Phase II results expected by year-end.
P&L Performance and Capital Allocation Strategy
The company reported strong P&L performance, with gross margin reaching approximately 85% in Q2, up 90 basis points sequentially, driven by the revenue mix from iDose and Epioxa. Management's philosophy prioritizes prudent investment in commercial launches and R&D to maximize top-line growth, while also focusing on operating leverage and cash flow generation. Full-year operating expenses are projected around $600 million, reflecting these strategic investments.
iDose TR Reimbursement Landscape and LCD Outlook
Management expressed confidence in the iDose TR Local Coverage Determinations (LCDs), citing overwhelming support from physicians and medical societies during public comment periods. While no statutory timeline exists, the company anticipates a more favorable final LCD. They emphasized that even with potential restrictions, a large market of 500,000-600,000 annual SLT procedures provides significant opportunity for iDose TR, and they would strenuously object to any clinically inappropriate final policies.
Epioxa Gross-to-Net and Site of Care Dynamics
The net realized average selling price for Epioxa is estimated around $60,000, factoring in Medicaid pricing and other required discounts. The O2N system deployment covers 85% of the U.S. population, with a pipeline to reach 95%, leveraging existing Tier 1 and Tier 2 customer sites. While some experienced sites use buy-and-bill, community practices lean on the Specialty Pharmacy option, with a shift to buy-and-bill expected to evolve over several years as confidence in consistent approvals grows.